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Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography (HEAL)

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ClinicalTrials.gov Identifier: NCT01689688
Recruitment Status : Unknown
Verified September 2013 by Toshiro Shinke, MD, PhD, Kobe University.
Recruitment status was:  Recruiting
First Posted : September 21, 2012
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Toshiro Shinke, MD, PhD, Kobe University

Brief Summary:
The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.

Condition or disease
Coronary Heart Disease

Detailed Description:

Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis.

On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium.

Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort
EES-XIENCE V
Groups who were treated with XIENCE V® everolimus eluting stent



Primary Outcome Measures :
  1. The percentage of neointimal coverage [ Time Frame: 12 months ]
    The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography


Secondary Outcome Measures :
  1. The percentage of neointimal coverage [ Time Frame: 3 months ]
  2. The percentage of neointimal coverage [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are percutaenous coronary intervention and stenting and eligible to receive dual antiplatelet therapy at least more than 6 month.
Criteria

Inclusion Criteria:

  1. Older than 20 years old.
  2. Indication of PCI.
  3. To agree to review and record all the clinical course in this research protocol.
  4. The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
  5. Informed concent with the document signed by the patients.

The patient have to correspond to all the above items at the time of registration.

Exclusion Criteria:

  1. The patient who died during the research
  2. The patient with Stent thrombosis during the research.
  3. Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
  4. Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30)
  5. The patient excluded from a safety of a thiazolidine derivative.

lesion exclusion criteria

  1. left main artery
  2. severe calcification
  3. stent restenosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689688


Locations
Japan
Kobe University Graduate School of Medicine Recruiting
Kobe, Hyogo, Japan
Contact: Toshiro Shinke, MD, PhD    +81.78.382.5846    shinke@med.kobe-u.ac.jp   
Principal Investigator: Toshiro Shinke, MD, PhD         
Sponsors and Collaborators
Kobe University
Investigators
Principal Investigator: Toshiro Shinke Kobe University Graduate School of Medicine

Responsible Party: Toshiro Shinke, MD, PhD, Associate Professor, Kobe University
ClinicalTrials.gov Identifier: NCT01689688     History of Changes
Other Study ID Numbers: KobeU-001
R000008722 ( Other Identifier: UMIN )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents